Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer
Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 prostate-cancer
Started May 1999
Shorter than P25 for phase_1 prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedSeptember 1, 2005
August 1, 2005
August 30, 2005
August 30, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of adenocarcinoma prostate cancer
- Prostate cancer deemed to be unresponsive or refractory to hormone therapy
- An ECOG performance status of 0 or 1
You may not qualify if:
- Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- Previous chemotherapy, biological or immunotherapy for cancer
- Previous gene therapy for cancer
- Significant cancer related pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cell Genesyslead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
May 1, 1999
Study Completion
January 1, 2001
Last Updated
September 1, 2005
Record last verified: 2005-08